Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Blood Patch, Standard of Care (per Physician).
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
A postoperative autologous blood patch (ABP) intervention trial for patients who underwent lung resection for cancer to examine its effectiveness in preventing a prolonged air leak. AIM 1: To determine the safety and efficacy of autologous blood patch (ABP) as a means to reduce the rate of prolonged air leak (PAL) after lung cancer resection AIM 2: To prospectively examine variation in morbidity and quality of life between patients with and without a PAL
Detailed description
The plan for this trial is to establish the safety and efficacy of ABP as a means of reducing PAL following lung cancer resection. Patients with an air leak on the morning of postoperative day 3 after elective lung resection for cancer will be randomized to ABP on postoperative day 3 and day 4 (if an air leak remains present), or standard care (n=60 per arm). This will be a multi-institutional randomized, controlled trial open for enrollment at centers in the United States and Canada. The study methods and design are compliant with the Consolidated Standards of Reporting Trials (CONSORT).
Subjects will be consented on postoperative day 3, with autologous blood patch intervention occurring on day 3 or day 4. If subjects are randomized to the ABP arm of the trial, they will receive 60-100 ml of autologous blood sterilely drawn from a peripheral vein and immediately instilled into the chest tube.
Subjects will then follow up either in clinic or via telephone to answer the questionnaire. If the subject is being seen in person, they will be handed a questionnaire form to complete. This form will be kept and stored as source documentation. If the patient is answering the questionnaire via telephone, the study team personnel will record their answers on the questionnaire form, indicating it was completed by the subject but recorded by study team personnel. A telephone encounter note will be recorded and stored as source with the completed questionnaire. Follow up occurs at 30 days (+/-5 days) postoperatively.
Interventions
- Procedure Autologous Blood Patch
All patients will be assessed on the morning of postoperative Day 3 and 4 for the presence of an air leak. If an air leak is present, 60-100 ml of autologous blood will be drawn from a peripheral vein and immediately instilled into the chest tube. The individual who draws blood is that the discretion of the site principal investigator. The tubing will be elevated over an IV pole while the patient remains in bed, moving position every 15 minutes for 1 hour to distribute the blood throughout the p - Procedure Standard of Care (per Physician)
Patients randomized to Standard of Care will be treated as their surgeon would as routine. This may mean postoperative observation, of another type of intervention.
Primary outcome measures
- Prolonged Air Leak >5 days [Time frame: Within 30 Days]
- Hospital Length of Stay [Time frame: Within 30 Days]
- Readmission within 30 days [Time frame: Within 30 Days]
- In hospital mortality [Time frame: Within 30 Days]
- 30-day Mortality [Time frame: Within 30 Days]
Eligibility criteria
Inclusion criteria
- Patients who underwent elective wedge resection, segmentectomy, lobectomy, or bilobectomy for suspected non-small cell lung cancer
- Patients that have reviewed and signed the Informed Consent Form, had an opportunity to ask questions, and consent to have their de-identified data included in the study
- Patients who have an air leak on the morning of postoperative Day 3
- Age ≥18 years old
Exclusion criteria
- Patients who undergo pneumonectomy, sleeve lobectomy, chest wall or diaphragm resection, or bilateral procedures.
- Age < 18 years old
- Women who are pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Rush University Medical Center — Chicago
Publications
- U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999-2013 Incidence and Mortality Web-based Report. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; 2017. Available at: www.cdc.gov/uscs
- Stephan F, Boucheseiche S, Hollande J, Flahault A, Cheffi A, Bazelly B, Bonnet F. Pulmonary complications following lung resection: a comprehensive analysis of incidence and possible risk factors. Chest. 2000 Nov;118(5):1263-70. doi: 10.1378/chest.118.5.1263. PMID 11083673
- Brunelli A, Monteverde M, Borri A, Salati M, Marasco RD, Fianchini A. Predictors of prolonged air leak after pulmonary lobectomy. Ann Thorac Surg. 2004 Apr;77(4):1205-10; discussion 1210. doi: 10.1016/j.athoracsur.2003.10.082. PMID 15063235
- Isowa N, Hasegawa S, Bando T, Wada H. Preoperative risk factors for prolonged air leak following lobectomy or segmentectomy for primary lung cancer. Eur J Cardiothorac Surg. 2002 May;21(5):951. doi: 10.1016/s1010-7940(02)00076-3. No abstract available. PMID 12062302
- Liang S, Ivanovic J, Gilbert S, Maziak DE, Shamji FM, Sundaresan RS, Seely AJE. Quantifying the incidence and impact of postoperative prolonged alveolar air leak after pulmonary resection. J Thorac Cardiovasc Surg. 2013 Apr;145(4):948-954. doi: 10.1016/j.jtcvs.2012.08.044. Epub 2012 Sep 13. PMID 22982031
- Gilbert S, Maghera S, Seely AJ, Maziak DE, Shamji FM, Sundaresan SR, Villeneuve PJ. Identifying Patients at Higher Risk of Prolonged Air Leak After Lung Resection. Ann Thorac Surg. 2016 Nov;102(5):1674-1679. doi: 10.1016/j.athoracsur.2016.05.035. Epub 2016 Jul 22. PMID 27457828
- Attaar A, Winger DG, Luketich JD, Schuchert MJ, Sarkaria IS, Christie NA, Nason KS. A clinical prediction model for prolonged air leak after pulmonary resection. J Thorac Cardiovasc Surg. 2017 Mar;153(3):690-699.e2. doi: 10.1016/j.jtcvs.2016.10.003. Epub 2016 Oct 14. PMID 27912898
- Lee L, Hanley SC, Robineau C, Sirois C, Mulder DS, Ferri LE. Estimating the risk of prolonged air leak after pulmonary resection using a simple scoring system. J Am Coll Surg. 2011 Jun;212(6):1027-32. doi: 10.1016/j.jamcollsurg.2011.03.010. Epub 2011 Apr 13. PMID 21489831
Identifiers
NCT: NCT04954625 · 19072606